The purpose of this study is to determine if the radiotracer, \[68Ga\]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.
Age ≥ 18 years.
Patients with unresectable locally advanced or metastatic cancer who are eligible for standard of care treatment with HER2-targeted therapy per the discretion of their treating physician for an FDA-approved indication. Patients who are planning to start HER2-targeted therapy at the time of study enrollment. Patients who have recently begun HER2 treatment and have received no more than 6 cycles will be eligible for enrollment.
Must have a previous biopsy demonstrating HER2 expression in at least one lesion (HER2+ solid cancer, or breast cancer patients who are HER2+ or HER2-low) as defined by IHC and FISH studies or with HER2 amplification as defined by a liquid biopsy that was done as standard of care testing for the patient's cancer type.
Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver.
Measurable sites of disease only in the liver.
Inability to comply with study procedures.
Hypersensitivity or allergy to any component of [68Ga]Ga-ABY-025.
Pregnant or breastfeeding.
Single group
[68Ga]Ga-ABY-025
DrugSubjects receive a tracer dose of \[68Ga\]Ga-ABY-025 and will receive a PET/CT scan a few hours after the injection.
Determine safety of [68Ga]Ga-ABY-025 PET by assessing for adverse events following the injection and PET imaging.
Outcome Measure: After study enrollment, subjects will receive \[68Ga\]Ga-ABY-025 infusion and undergo PET/CT scan. Patients will be immediately assessed for adverse events within the first 30 minutes of infusion and 2-7 days post-infusion from the study coordinator. Adverse events will be monitored up to 21±14 days following the infusion of study drug. Repeat infusion and imaging will be obtained either at the time of treatment discontinuation or at 12 months from study consent and will have the same safety monitoring parameters. While there are expected adverse events related to anti-cancer therapy, we will specifically be reporting adverse events that are "definitely related" or "probably related" to the study agent.
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